1. Field of Invention
This invention relates to managing and administering medications, especially to automated system for managing and administering medications.
2. Description of Prior Art
Presently, a doctor prescribes medication for a patient by writing on a standard prescription form, calling a prescription-filling facility, or entering into a specialized computer system (such as Computerized Physician Order Entry, or CPOE) with the prescription information, which normally includes the doctor's information, the patient's information, the medication identifier (name), and the usage information. The usage information usually includes schedule (e.g., one unit dose every morning, one unit dose every four hours, etc.), unit dosage (e.g., three tablets, 10 ml, etc.), and total daily dosage (e.g., 9 tablets, 40 ml., three unit doses, etc.).
For an inpatient, the prescription is usually filled by an in-hospital medication administration unit, and a nurse administers each unit-dose medication to the patient following the usage information.
For an outpatient, the prescription is usually filled by a pharmacy, and a pharmacist enters the prescription information into the pharmacy's computer system. The pharmacy's computer system prints a medication label with human-readable medication information (including medication identifier and the usage information, to be affixed on the container or bag). The patient has to follow the usage information to take the medication.
Taking a wrong medication, with a wrong dosage, or at a wrong time could result in ineffective treatment, complication, or even death. Many methods, systems, and devices have been developed or proposed in prior art to help nurses and patients adhere to usage information.
The healthcare facilities (hospitals, nursing homes, etc.) have adopted regulations and procedures in administering medication. According to the prior art, there are medication-administering systems for healthcare facilities, where the computer matches patient identification with prescribed medication before administering a unit-dose medication. The FDA has ruled (effective in 2006) that healthcare facilities must use barcode for patient identification matching.
For home-consumed medications, the responsibility for following usage information falls completely on the patient or the family members. In addition to prescription medications (Rx), a person may also take over-the-counter (OTC) medications and dietary supplements, which also have their own usage information. That further complicates the matter.
For simplicity and definiteness, unless otherwise specified, the term “medication” will in general include Rx, OTC, dietary supplements, with all application types (intake, topical, injection, inhaler, etc.) in all forms (liquid, gaseous, ornament, powder, pill, capsule, etc.). The term “user” will be used to refer to a person who takes medication. The term “scheduled event” will generally refer to an event that is scheduled to take place at a specified moment, but mostly it will refer to a unit dose of certain medication at a scheduled time.
According to the prior art, a user can choose one or several devices described in the following to assist him/her adhere to usage information at home.
A user can use a bulk medication organizer. A bulk medication organizer has multiple storage compartments, each for a type of medication. Examples of prior art designs include: U.S. patent application Pub. No. 2002/0130138 and 2001/0002025, U.S. Pat. Nos. 4,785,932 and 4,638,923. Bulk medication organizers represent the design of the lowest automation among all prior art designs. It is just slightly more organized than leaving medications in their original containers. Besides specific shortcomings of each individual design, bulk medication organizers suffer from the following common disadvantages:    (A1) They provide very limited help.    (A2) User has to label each storage compartment with usage information.    (A3) User has to keep time and track scheduled events with other means.
A user can use a dose-compartment medication organizer. A dose-compartment medication organizer has multiple dose compartments, each holding one or several medications to be taken at same time. Examples of prior art designs include: U.S. patent application Pub. No. 2005/0109658 and 2004/0256406, U.S. Pat. Nos. 6,554,136, 6,338,535, and 5,838,224. Besides the specific shortcomings of each individual design, dose-compartment medication organizers suffer from the following common disadvantages:    (B1) User has to figure out a loading-scheduling plan according to the usage information.    (B2) User has to follow the loading-scheduling plan to load the medications into the dose compartments.    (B3) Loading becomes dramatically complicated and tricky as the number of medications increases.    (B4) Practically they are not suitable for medications that require precise timing, or have very different or complex schedules.    (B5) It is very difficult to add a new medication since user has to find an existing group with compatible schedule and identify the corresponding dose compartments.    (B6) It is difficult to delete (cancel) a medication since the user has to search all dose compartments for that medication.    (B7) User has to label each dose compartment with schedule except for very simple and regular schedules (e.g., every morning).    (B8) User has to keep time and track the scheduled events with other means.
A user can use a medication reminder. A medication reminder produces visual, audible, or tactile alarm for scheduled events to remind the user. Examples of prior art designs include: U.S. patent application Pub. No. 2005/0150805, 2005/0041531, and 2003/0146848, and U.S. Pat. No. 6,845,064. The medication reminder may be equipped with a display or speaker to indicate the medication and unit dosage to be taken. A medication reminder may be used for a single medication, a group of medications with same schedule, or several medications with different schedules. Besides the specific shortcomings of each individual design, medication reminders suffer from the following common disadvantages:    (C1) User has to set the clock.    (C2) User has to program the medication reminder for each scheduled event.
Many prior art designs combine medication reminder with bulk medication organizer or dose-compartment medication organizer. Examples of prior art designs include: U.S. patent application Pub. No. 2004/0182873 and 2001/0022758, and U.S. Pat. Nos. 6,131,765, 5,990,782, and 5,826,217. Such designs overcome some of the disadvantages of the bulk (A2 and A3) and dose-compartment medication organizers (B7 and B8), but they incorporate the disadvantages of the medication reminder (C1 and C2).
A user can use a dose-compartment medication dispenser. A dose-compartment medication dispenser is similar to the above described dose-compartment medication organizer, except using motors to align (rotate) the dose-compartment with the outlet. Examples of prior art designs include: U.S. patent application Pub. No. 2003/0127463 and 2002/0118604, and U.S. Pat. Nos. 6,834,775, 5,159,581, and 4,573,606. Dose-compartment medication dispensers incorporate the disadvantages (B1) to (B6) of dose-compartment medication organizers and the disadvantages (C1) and (C2) of medication reminders. They have further common disadvantages:    (D1) Since now the order of dose compartments is tied to the sequence of dispensing, loading the medication and programming the scheduled events become even more complicated.    (D2) Most of them can only handle simple schedules (e.g., three times everyday).    (D3) Even if some of them can handle complex schedules, programming such schedules and loading the medications accordingly are very complicated and tricky, hence, practically prohibitive.
A user can use a bulk medication dispenser. Examples of prior art designs include U.S. patent application Pub. No. 2003/0222090 and 2002/0070227, U.S. Pat. Nos. 6,607,094 and 4,953,745. Bulk medication dispensers store each type medication in a storage compartment, similar to bulk medication organizers, but they can dispense the unit-dose medications according to scheduled events. Although bulk medication dispensers offer several advantages over other groups, e.g., efficient storage, easier loading and deleting, they suffer from the following common disadvantages:    (E1) User has to set the clock.    (E2) They typically require substantial user programming    (E3) They require complex user-programming interfaces (some prior art designs require a PC to program a bulk medication dispenser).    (E4) User has to find appropriate storage compartment (original one for a refill or empty one for new) to load the medication.    (E5) User has to tell the system (through additional user programming) which medication is stored in which compartment.
As explained above, all these prior art designs require manual effort, or programming effort, or both. Generally speaking, the designs with low level of automation require low level of programming effort but high level of manual effort, the designs with high level of automation require low level of manual effort but high level of programming. This is a dilemma for the prior art designs. Both manual task and programming not only make prior art devices difficult to use, but also can cause errors.
These prior art designs have overlooked a crucial fact, namely, the majority of medication users by far are elderly people, who are least willing and able to perform such manual and programming tasks. Even if a device has some wonderful features, complicated manual operation or user programming could cause the users not to utilize these features, not to utilize them to their fullest capacity, or possibly to abandon it all together.
Furthermore, the designs that require user programming, especially those require substantial or complex user programming, are not suitable for some users, especially vision-impaired users. Some devices and designs are claimed to be suitable for vision-impaired users since audible alarms and voice messages are used instead of visual displays. As long as these devices and designs require user programming and clock setting, they pose a severe and often prohibitive challenge to vision-impaired users.
Methods have been developed or proposed in prior art to ease user operations, but most of them merely shift the user operation burden to professionals.
A user can have his/her medications prepackaged and use a prepackaged medication dispenser. A prepackaged medication dispenser dispenses unit-dose packages, each unit-dose package containing one or several medications to be taken at same time. This is similar to a dose-compartment medication dispenser, except that the unit doses are prepackaged by medication provider, instead of being loaded by the user. Examples of prior art designs include: U.S. patent application Pub. No. 2004/0158350 and 2003/0042167, U.S. Pat. Nos. 6,848,593, 5,221,024, and 4,797,283. Although it relieves user from grouping and loading the medications, this method imposes most restrictions upon the users among all prior art methods. Besides specific shortcomings of each individual design, this method suffers from the following common disadvantages:    (F1) All medications of a user have to come from a single provider that prepackages them, or they are left out.    (F2) Only the medications of same schedule can be prepackaged (together).    (F3) Practically, it is only suitable for long-term medications and medications with regular and simple schedules (otherwise, packaging instructions and programming are likely to be too complicated).    (F4) Each specific design of dispenser can only work with one type of package/magazine and vise versa.    (F5) Each specific design of packages requires a specific packaging line.    (F6) A user of a particular prepackaged dispenser is usually stuck with a specific provider (because of F4 and F5).    (F7) Each type of package/magazine can only handle certain types of medications.    (F8) Each type of package/magazine is only suitable to a certain amount of medications.    (F9) Only certain types of medications are suitable for pre-packaging.    (F10) It is impossible to add a new medication (user has to discard medications already packaged and reorder).    (F11) It is impossible to change the sequence of the medications (user has to discard medications already packaged and reorder).    (F12) It is very difficult to delete a medication unless user can identify it by appearance and discard them from every unit-dose package.    (F13) Cost is high due to service fees and wasted medications.
Generally speaking, any change in user's medication usually means discarding all prepackaged medications and reorder, since any confusion or error may have devastating consequences.
U.S. patent application Pub. No. 2004/0133305 and 2002/0000917, and U.S. Pat. No. 5,408,443 suggested that medication providers, e.g., pharmacies, provide a pre-programmed device (medication reminder plus storage, or medication dispenser) with filled medication. Besides specific disadvantages of each individual design, this method suffers from the following common disadvantages:    (G1) It is subject to cross contamination and hygiene problems since the devices will be passed to different users.    (G2) User has to bring the device from and to the medication provider for new medication, returning (when medication finishes), and having it reprogrammed (if doctor has directed any change).    (G3) It drastically changes the routines and increases the workload of the medication provider.    (G4) It generates additional service cost.    (G5) It can only be used for prescription medications (no help for non-prescription medications).
Also, remote administration of medication has been proposed. Examples of prior art designs include: U.S. patent application Pub. No. 2004/0210488, 2004/0172163, 2002/0147526, and 2002/0113077.
The basic idea of remote administration of medication is to let a caregiver (physician, nurse, or other qualified individual) to program the scheduled events for a user via Internet on a dedicated server. The dedicated server in turn controls a medication dispenser at user's residence (remote-controlled dispenser, usually a prepackaged dispenser) via a dedicated telephone line or other communication means (cable or wireless). Some prior art designs further require a local PC to control the dispenser. Basically, the caregiver takes over the manual and programming burden from the user. Besides specific shortcomings of each individual design, remotely controlled medication systems have the following common disadvantages:    (H1) They require large supporting system including infrastructure and personnel, which in turn require considerable initiative and investment.    (H2) The supporting systems must keep all medical record of a user, track and administrate all medications of the user.    (H3) They require collaboration and coordination of many parties, including the insurance company and other caregivers of the user.    (H4) Once enrolled, a user is likely to be stuck with a system for a long time since it is difficult to switch to another system.    (H5) The Internet can hardly be secured completely, and computer systems, especially large ones, can hardly avoid malfunction; hence, the user is exposed to additional risks, such as stolen personal and medical information, administration of a wrong medication, a wrong dose, or a wrong time.    (H6) The caregiver has to come to the user's home to load the dispenser periodically or anytime there is a change in user's medication.    (H7) A high maintenance cost is charged to the user.
It has been proposed in prior art to use memory devices to store machine-readable information. Examples of prior art designs include: U.S. patent application Pub. No. 2004/0039481, 2003/0099158, 2002/0067270, 2002/0027507, and 2001/0028308, U.S. Pat. Nos. 6,611,733, 6,529,446, 6,380,858, 6,335,907, 6,294,999, 6,259,654, 5,852,590, 5,522,525, and 5,181,189 proposed similar ideas where memory strip, IC chip, or barcode that contains schedule and unit-dosage information were attached to (or made on) the package of each medication. When the package is correctly mounted on the medication device, the memory strip, IC chip, or barcode are connected or aligned with a reader, so the stored information can be read and used to set the scheduled events. These designs have the following common disadvantages:    (I1) They require specially designed medication containers.    (I2) The memory strip, IC chip and barcode have to be affixed on the packages with accurate position and orientation.    (I3) They require the specially designed medication containers be accurately mounted on the device such that the memory strip, IC chip, or barcode (hence the medication) are aligned with the reader or a set of electrical leads connect with that of the device.
In addition, U.S. Pat. Nos. 6,335,907 and 5,181,189 in this group require    (I4) each medication to use a device.
U.S. patent application Pub. No. 2004/0039481, 2003/0099158, 2002/0067270, 2002/0027507, and 2001/0028308, U.S. Pat. Nos. 6,611,733, 6,529,446, 6,380,858, 6,294,999, 6,259,654, 5,852,590, and 5,522,525 in this group require    (I5) redundant components (memory readers and control units), each for a medication.
When used with a remote sensing method, such as RF tags as suggested in these prior art designs, multiple readers are    (I6) subject to interference.
U.S. Pat. Nos. 6,281,798, 6,119,892, 6,032,085, and 4,695,954 proposed designs with detachable card (smart card or magnetic card) that stored the machine-readable information. The detachable card is inserted into the proposed user devices that can read the information and set the scheduled events. Although these designs can handle multiple medications, without providing a convenient method for user to load the medications into the devices, they require:    (I7) the device or a detachable storage to be filled by a pharmacy, or    (I8) additional user operation, additional components, and additional controls.
In general, all these prior art designs with memory devices    (I9) have limited applications,    (I10) restrictive configurations, and    (I11) very little flexibility.
Furthermore, all these designs with memory devices    (I12) require users to set clock.
Finally, all of the prior art programmable devices and systems have three common disadvantages:    (J1) The methods of user-request expression (loading, refilling, modifying, deleting, taking emergency dose, etc) are too complicated and complicated user-input interfaces are required.    (J2) They do not provide guided user operations.    (J3) They do not provide automatic medication-storage mapping.
In order to achieve certain level of automation, such as automatic dispensing, a mechanism is needed for the system to tie the medication with its storage. For definiteness, this mechanism will be called medication-storage mapping. When a user loads a medication to a prior art system, the user not only has to program the scheduled events but also has to tell the system where the medication is stored through additional user programming, so that the system can establish the medication-storage mapping. This kind manual medication-storage mapping not only is cumbersome but also can cause errors, prompting some prior art designs to require pharmacy to load the medications, or to use redundant components or devices, each handling one medication.
In conclusion, despite the improvements of the method and system for managing and administering medications, many problems remain unsolved, or their solutions remain unsatisfactory. There is definitely a need for a method and system that substantially overcome the aforementioned disadvantages of the prior-art designs and provide overall satisfactory results.